Pharmacists and Controlled Substances Prescriptions

Aaron M. Gilson, MS, MSSW, PhD

Disclosures

May 15, 2009

Question

If physicians are protected by law when they refuse to prescribe opiates for chronic pain patients, what about a pharmacist who refuses to fill the prescription once it's written?
April Nicole, PharmD

Response from Aaron M. Gilson, MS, MSSW, PhD
Senior Scientist, Paul P. Carbone Comprehensive Cancer Center, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin

This question is based on the truism that physicians are protected by law when they refuse to prescribe opioid analgesics to treat patients with chronic pain. In fact, in 2004, the Federation of State Medical Boards (the Federation) updated its model policy template to specifically recognize that the undertreatment of pain should be considered a departure from an acceptable standard of practice and, therefore, grounds for regulatory investigation and discipline.[1] To date, almost 20 state medical boards have adopted the Federation's revised model containing the provision equating undertreatment with substandard practice.[2] In addition, case law has proven that healthcare practitioners and organizations failing to meet recognized standards of care will not only be held morally accountable but also can be held legally and monetarily accountable.[3,4]

These judicial and regulatory trends create an environment in which, if relief of pain and suffering is not made a clinical priority, there can be enhanced liability. In addition, the recent publication of a national report recognizing the treatment of pain as a basic human right, and calling on all countries to make safe and effective pain management an urgent priority, has the potential to further reinforce the importance of this clinical issue.[5] Just because physicians historically have not been held liable for refusing to prescribe opioids does not necessarily mean that such practice is protected by law.

Dr. David Brushwood concluded in a previous Ask the Expert response that the legal requirements underlying controlled substances prescriptions provide "effective cover for healthcare providers who fail to issue or honor [such prescriptions] when a patient's need is in any way questionable." Specifically, a prescription for a controlled substance must be "issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice."[6] Pharmacists have a legal obligation to evaluate the legitimacy of a controlled substance prescription issued by a practitioner, which is generally referred to as the pharmacist's "corresponding responsibility."[7,8]

Of course, erroneous beliefs can form the basis of determinations about a prescription's legitimacy. A survey of Wisconsin pharmacists demonstrated that a notable minority had incorrect knowledge about what is legitimate practice under federal and state law, and 36% considered extended prescribing of opioids to be either a violation of law or unacceptable medical practice.[9] If implemented into practice, holding such beliefs can lead to a refusal to fill a valid prescription and to a denial of needed medications.[10] An ability to distinguish between acceptable and unacceptable practice by today's standards, and knowing what currently is lawful or unlawful, remains central to a pharmacist's responsibility to dispense valid prescriptions while not dispensing those that are not legitimate. I concur with Marcus and Cohen's assessment that, "It is at least as great a violation of [pharmacists'] professional responsibility to refuse to fill controlled substance prescriptions without adequate reason as it is to fill without thought any controlled substances prescription [they] receive" (p. 235),[8] even if pharmacists generally have not been held liable for such practice.

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